On October 19, 2016, 52 participants from academia, industry, non-profit organizations, professional associations and regulatory agencies gathered at Harvard Faculty Club for a workshop on “Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of Framework.”
Fifteen case studies from five countries and results of a global survey showed that the core competencies have been utilized for innovative workforce development in the clinical research enterprise–for re-shaping academic curricula, revising job descriptions, and educating and certifying professionals in competencies for conducting clinical research. Next steps will include revisions of competencies based on feedback received, levelling/tiering of competencies for different job descriptions, and, in a later phase, developing metrics, evaluation, training and educational resources.
The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences. Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.
This will be an opportunity to learn more about the application of the core competencies for those seeking to apply the competencies in their own environment. Also the workshop will provide an opportunity for participants to provide feedback and discuss potential future revisions for the competency framework. Potential future projects for the work group will also be discussed.
The MRCT Center and Peking University collaborated to develop a framework, harmonized to guidance from ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), regarding how countries can consider the importance of ethnic factors, trend consistency and the definition of region in the evaluation on drug efficacy and safety for the design of multi-regional clinical trials.
The MRCT Center and Peking University collaborated to develop a framework, harmonized to guidance from ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), regarding how countries can consider the importance of ethnic factors, trend consistency and the definition of region in the evaluation on drug efficacy and safety for the design of multi-regional clinical trials.
A workshop at Peking University on 26 October 2015 convened 50 academic leaders, regulatory officials including CFDA, the PMDA, US FDA, and academic and industry leaders in a small, invitation-only closed meeting. Phase one of our project team efforts was presented to the global regulators, focusing on the scientific principals underlying global regulatory decision-making for multi-regional clinical trials.
Key presentations included:
Bob O’Neill (US FDA) History and rationale for ICH E-5 – Dr. O’Neill set the stage for how bridging may be achieved from extrapolation to utilization of data from one region to another.
Leigh Verbois (Director US FDA China Office) – Dr. Verbois discussed how strong regulatory systems may be effectively driven through collaboration and key learning opportunities such as this workshop. She praised the Center of Excellence concept that is being launched in Asia for training of regulators as one that will effectively build capacity in the region.
Workgroup 1 (Chen Gang, Johnson & Johnson; Tony Guo, Merck; Barbara Bierer, Rebecca Li, MRCT Center) – Proposed a new model for how consistency may be defined. This model contemplates 3 levels of consistency based on disease category.
Workgroup 2 (Luyuan Dai, Boehringer Ingelheim; Yangfeng Wu, Peking University; Pei Hu, Peking Union Medical College Hospital) – Discussed guidelines (or an algorithm) on how external and internal factors in different regions may be utilized to weigh outcomes for drug efficacy and/or safety.
Region workgroup (Laurie Letvak, Novartis) presented a new vision for region predicated on defining region as a subpopulation.
A full set of slide presentations is available for MRCT sponsors by clicking here. Slides from Consistency Workgroup 1 are available in Chinese here.
We at the MRCT Center, with our friends and colleagues, mourn the passing of Padma Shri Prof Ranjit Roy Chaudhury, announced on the morning of October 27, 2015.
Prof Roy Chaudhury was a visionary, mentor and friend, instrumental to medicine, health care delivery, medical education, drug regulation, and clinical research in India. He worked tirelessly to improve the clinical research enterprise in India, knowing that only with robust clinical research programs can India hope for the rapid availability of new medicines and treatments to the people of India. He was a leader at a time when leadership was essential, an enthusiast at a time of pessimism, and a consolidator at a time of dissonance. He greeted all with a calming smile and a warm, welcoming and earnest handshake that spoke inclusion and acceptance. He was quiet but incisive.
Many of the most significant reforms in the regulatory environment in India over the last few years were outlined in recommendations that emanated from the Ranjit Roy Chaudhury Expert Committee to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs, at the direction of the Ministry of Health and Family Welfare. Those recommendations have largely been implemented, and have helped to create clinical research built on patient safety, quality and underlying scientific and ethical principles. His influence will be forever felt in the restoration of clinical research in India; the work is not finished, but his legacy is palpable. We owe it to him, and to the people of India, to ensure that new medicines and treatments, new diagnostics and therapeutics, are again available through trustworthy and robust clinical research functioning with appropriate regulatory oversight.
We have all lost a leader and friend in Prof Roy Chaudhury. We extend our heartfelt condolences to his family, to the clinical research community, and to the people of India.
Barbara E. Bierer, MD Mark Barnes, JD LLM Rebecca Li, PhD
